| Primary Device ID | D768SYN615DC60 |
| NIH Device Record Key | a856e8ac-513e-48f1-920f-c0969cd3a846 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OCT |
| Version Model Number | SYN615D-C6 |
| Catalog Number | SYN615D-C6 |
| Company DUNS | 787471015 |
| Company Name | KEYSTONE DENTAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(781)328-3515 |
| cyoung@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D768SYN615DC60 [Primary] |
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[D768SYN615DC60]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-02-11 |
| D768TSITPA0 | Abutment Screw |
| D768TSIT20 | Retention Screw |
| D768TSAF550 | Solid Abutment |
| D768TSAF40 | Solid Abutment |
| D768TSA6550 | Solid Abutment |
| D768TSA640 | Solid Abutment |
| D768SYN620DF60 | Angled Abutment |
| D768SYN620DC60 | Angled Abutment |
| D768SYN615DF60 | Angled Abutment |
| D768SYN615DC60 | Angled Abutment |
| D768SYN60 | Angled Abutment |
| D768SYN20DF60 | Angled Abutment |
| D768SYN20DC60 | Angled Abutment |
| D768SYN15DF60 | Angled Abutment |
| D768SYN15DC60 | Angled Abutment |
| D768ITSPANE0 | Passive Abutment |
| D768ITSPA0 | Passive Abutment |
| D768ITSGC1NE0 | Gold Sleeve |
| D768ITSGC10 | Gold Sleeve |
| D768ITS6PANE0 | Passive Abutment |
| D768ITS6PA0 | Passive Abutment |
| D768TT660 | Healing Abutment |
| D768TT650 | Healing Abutment |
| D768TT630 | Healing Abutment |
| D768TT620 | Healing Abutment |
| D768TT610 | Healing Abutment |
| D768TT600 | Cover Screw |
| D768TT450 | Healing Abutment |
| D768TT30 | Healing Abutment |
| D768TT20 | Healing Abutment |
| D768TT10 | Healing Abutment |
| D768TT00 | Cover Screw |
| D768PCAP6550 | Healing Cap |
| D768PCAP6400 | Healing Cap |
| D768ITSTC1NE0 | Temp Sleeve |
| D768ITSTC10 | Temp Sleeve |
| D768ITS6TC1NE0 | Temp Sleeve |
| D768ITS6TC10 | Temp Sleeve |